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CALM

The CALM Study: A delayed-start randomized controlled trial of guided online cognitive behavioral and circadian therapy for insomnia in people with comorbid anxiety. - CALM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58379
Enrollment
98
Registered
2025-11-19
Start date
2026-08-03
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia and Generalized Anxiety Disorder Insomnia and anxiety

Interventions

The intervention is a cognitive behavioural and circadian therapy for insomnia (CGCT-I), consisting of 5 modules over approximately 5–8 weeks.Module 1: Psychoeducation about sleep and insomnia, and th

Sponsors

Nederlands Herseninstituut
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Insomnia Severity Index (ISI) [Bastien, 2001] score = 10,Generalized Anxiety Disorder (GAD-7) [Spitzer, 2006] score =10,Between 18 and 45 years of ageSelf-considered capability of completing online questionnaires and diaries in Dutch.

Exclusion criteria

Exclusion criteria: People that have undergone cognitive behavioral therapy for insomnia (CBT-I) in the past three months or are currently receiving CBT-I (single question)Current diagnosis with bipolar or psychotic disorder (single question).

Design outcomes

Primary

MeasureTime frame
The primary outcome is the severity of anxiety symptoms, measured with the GAD-7 questionnaire.

Secondary

MeasureTime frame
Secondary outcome measures are:Changes in depressive symptom severity, measured with the PHQ-9. Baseline characteristics that predict which participants show short-term (up to 2 months) and long-term (10–12 months) clinical improvement.The extent to which clinical improvements are explained by changes in sleep and circadian rhythms, including subjective and objective sleep measures and the overnight regulation of emotional distress.

Countries

Netherlands

Contacts

Public ContactJ.E. Reesen

Nederlands Herseninstituut

info@slaapregister.nl020 566 5500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026